PKC · Class II · 21 CFR 888.3660

FDA Product Code PKC: Prosthesis, Total Anatomic Shoulder, Uncemented Metaphyseal Humeral Stem With No Diaphyseal Incursion, Semi-constrained

FDA product code PKC covers uncemented metal total anatomic shoulder prostheses cleared for shoulder arthroplasty.

These implants achieve fixation through biological ingrowth or ongrowth into porous-coated surfaces rather than bone cement. Uncemented fixation is preferred in younger, more active patients where long-term biological fixation may outperform cemented alternatives.

PKC devices are Class II medical devices, regulated under 21 CFR 888.3660 and reviewed by the FDA Orthopedic panel.

Leading manufacturers include Exactech, Inc., Arthrex, Inc. and Smith & Nephew, Inc..

19
Total
19
Cleared
165d
Avg days
2015
Since
Growing category - 5 submissions in the last 2 years vs 2 in the prior period
Review times improving: avg 142d recently vs 173d historically

FDA 510(k) Cleared Prosthesis, Total Anatomic Shoulder, Uncemented Metaphyseal Humeral Stem With No Diaphyseal Incursion, Semi-constrained Devices (Product Code PKC)

19 devices
1–19 of 19
Cleared May 01, 2026
FX V135 EASYTECH® Shoulder System
K254154
FX Shoulder Solutions, Inc.
Orthopedic · 130d
Cleared Oct 03, 2025
AETOS Shoulder System Stemless Humeral Prosthesis
K252129
Smith & Nephew, Inc.
Orthopedic · 88d
Cleared Dec 23, 2024
INHANCE INTACT™
K243248
Depuy Ireland UC
Orthopedic · 73d
Cleared Dec 11, 2024
OsseoFit Stemless Shoulder System
K241873
Zimmer, Inc.
Orthopedic · 167d
Cleared Nov 20, 2024
AETOS Shoulder System Stemless Humeral Prosthesis
K240716
Smith & Nephew, Inc.
Orthopedic · 250d
Cleared Mar 17, 2023
SMR Stemless Anatomic
K221758
Lima Corporate S.P.A.
Orthopedic · 274d
Cleared Sep 14, 2022
Tornier Perform Humeral System – Stemless
K220418
Tornier, Inc.
Orthopedic · 212d
Cleared Mar 11, 2022
Shoulder Innovations Total Shoulder System
K213615
Shoulder Innovations, Inc.
Orthopedic · 116d
Cleared Jan 19, 2022
GLOBAL ICON Stemless Shoulder System
K212683
Depuy(Ireland)
Orthopedic · 148d
Cleared Jul 16, 2021
Ignite Stemless Anatomic Shoulder System
K203108
Ignite Orthopedics, LLC
Orthopedic · 274d
Cleared Feb 16, 2021
Easytech® Anatomical Shoulder System
K201391
Fx Shoulder USA, Inc.
Orthopedic · 265d
Cleared Nov 20, 2020
Arthrex Eclipse Titanium Humeral Head
K203100
Arthrex, Inc.
Orthopedic · 37d
Cleared Jul 08, 2020
Arthrex Eclipse Shoulder Prosthesis System
K201542
Arthrex, Inc.
Orthopedic · 29d
Cleared Jun 03, 2020
AltiVate Anatomic Canal-Sparing (CS) Shoulder
K193226
Encore Medical, L.P.
Orthopedic · 194d
Cleared Apr 29, 2020
Exactech® Equinoxe® Stemless Humeral Components
K192097
Exactech, Inc.
Orthopedic · 268d
Cleared Apr 22, 2019
Comprehensive Nano Stemless Shoulder
K182516
Biomet Manufacturing Corp
Orthopedic · 221d
Cleared Mar 09, 2018
Exactech Equinoxe Stemless Shoulder
K173388
Exactech, Inc.
Orthopedic · 130d

About Product Code PKC - Regulatory Context

510(k) Submission Activity

19 total 510(k) submissions under product code PKC since 2015, with 19 receiving FDA clearance (average review time: 165 days).

Submission volume has increased in recent years - 5 submissions in the last 24 months compared to 2 in the prior period - suggesting growing market activity in this device classification.

FDA 510(k) Review Time - PKC Product Code

Recent submissions under PKC have taken an average of 142 days to reach a decision - down from 173 days historically, suggesting improved FDA processing for this classification.

PKC devices are reviewed by the Orthopedic panel. Browse all Orthopedic devices →